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Published on: July 13, 2019
Comparing Midline and Peripherally Inserted Central Catheters: A Randomized Feasibility Trial
Alina G Burek1,2, Kelsey Porada2, Matthew R Plunk1,2
1Children's Wisconsin, Milwaukee, Wisconsin.
Insights
A feasibility trial comparing peripherally inserted central catheters (PICCs) and midline catheters in children was not practical due to low PICC use. Further research may focus on catheter selection algorithms.
Area of Science:
- Pediatric vascular access
- Clinical trial feasibility
- Medical device comparison
Background:
- The optimal use of midline catheters versus peripherally inserted central catheters (PICCs) in pediatric patients requires further investigation.
- Durable vascular access is crucial for hospitalized children requiring medium-term (5-14 days) noncentral venous access.
Purpose of the Study:
- To assess the feasibility of a randomized controlled trial (RCT) comparing PICCs and midline catheters in children.
- To gather preliminary data on the effectiveness of these two vascular access devices.
Main Methods:
- A single-site study combined a randomized controlled feasibility trial (RCT) and a prospective observational study.
- Hospitalized children aged 2-17 years needing 5-14 days of vascular access were enrolled.
- Primary RCT outcome was a 4-measure feasibility assessment; secondary outcomes included time-to-removal and failure rates.
Main Results:
- Only 43 of 260 screened patients met eligibility criteria, primarily due to reduced PICC utilization.
- 35 patients were enrolled: 8 in the RCT (4 per arm) and 27 in the observational study.
- The RCT's enrollment goal was not met, but other feasibility metrics (enrollment rate, intervention adherence, acceptability, data completeness) were achieved.
Conclusions:
- A comparative trial of PICCs and midline catheters may not be feasible for evaluating midline catheter effectiveness in children due to decreased PICC use.
- Future research should consider hybrid effectiveness-implementation studies, potentially involving an intravenous catheter selection algorithm.
Objectives:
The most effective use of midline catheters in children is not understood. We aimed to (1) test the feasibility of a trial comparing peripherally inserted central catheters (PICCs) to midline catheters in hospitalized children in need of durable vascular access and (2) collect preliminary effectiveness data of the 2 devices.
Methods:
Our study combined a single site, randomized controlled feasibility trial (RCT, primary study) and a prospective observational study (alternative study) comparing PICCs to midline catheters. Hospitalized children aged 2 to 17 years in need of noncentral, medium-term vascular access (5-14 days) were enrolled for 1 year. The primary outcome of the RCT was a 4-measure feasibility outcome, and we had an enrollment goal of 30 participants/arm. Effectiveness outcomes (both studies) included time-to-device removal and all-cause failure.
Results:
Between August 2022 and August 2023, only 43 of 260 screened patients met eligibility criteria because of a decrease in eligible PICCs. A total of 35 patients were enrolled: 8 out of 10 in the RCT (4/arm) and 27 out of 33 in the alternative study (21 midline catheters, 6 PICCs). The RCT eligibility goal was not met. The other feasibility measures were met: (1) 80% of eligible patients enrolled, (2) 100% of eligible patients received the assigned intervention, (3) 96% of inserters found the study acceptable, and (4) there were no missing data.
Conclusions:
Because of a decrease in PICC use for noncentral, medium-term vascular access needs, a trial comparing devices may not be practical for assessing the effective use of midline catheters in hospitalized children. Next steps may include a hybrid effectiveness-implementation study evaluating an intravenous catheter selection algorithm that incorporates midline catheters.
